Interpretation of the Guidelines for the Review of Usability Engineering in Medical Device Registration
Background
One of the distinctive features of medical devices is the need for human-machine interaction to achieve their intended use. Issues related to the usability of medical devices have been prominent, with usage risks that cannot be ignored. In response, regulatory bodies in the United States, European Union, and other regions have released various guidelines and standards to strengthen the requirements for medical device usability. China officially implemented the GB 9706.1-2020 series of standards on May 1, 2023, which also specify usability requirements. The "Guidelines for the Review of Usability Engineering in Medical Device Registration" were formulated to promote the smooth implementation of these standards and enhance China's international influence in regulatory areas.
Scope
The guidelines apply to the registration applications for Class II and Class III medical devices concerning usability engineering but are not applicable to in vitro diagnostic reagents. Applicants can follow these guidelines for all medical device usability engineering activities.
Key Concepts
Usability engineering in medical devices involves using knowledge about human anatomy, physiology, psychology, behavior, and culture to design and develop devices that enhance usability. Usability refers to the characteristics of the user interface that ensure the safety, effectiveness, and ease of use of medical devices by the intended users in expected use scenarios. The core elements of usability include the user, use scenario, and user interface, focusing on the safety and effectiveness of medical devices during normal use.
Core Ideas
The guidelines focus on user interface design issues, considering usability engineering requirements from the perspective of medical device design and development. Based on the level of use risk, devices with high use risk must undergo comprehensive usability engineering lifecycle quality control and submit usability engineering research reports. Devices with medium or low use risk can conduct usability engineering based on the risk management process and submit use error assessment reports.
User Interface Verification and Confirmation
User interface verification and confirmation are crucial parts of medical device design verification and confirmation. Usability testing, based on observations and interviews with intended users in expected use environments, evaluates the user interface. Manufacturers can conduct summative usability tests in simulated or real use environments and may also engage third-party usability laboratories.
Relationship with Clinical Trials
User interface confirmation tests for some critical tasks could lead to serious harm or death of subjects, which cannot be executed in clinical trials. Clinical trials usually cannot replace user interface confirmation tests. However, data from clinical trials can support usability engineering by providing evidence of safe and effective use in real-world settings.
Import Considerations
For imported medical devices, differences in user and usage scenarios between domestic and international markets, as well as differences in usability engineering registration requirements, must be taken into account. In principle, imported medical devices should undergo user interface verification work in China based on their level of usage risk, unless detailed supporting materials are provided to demonstrate that the differences between domestic and international contexts do not significantly impact user interface verification.
- High-Risk Devices: Applicants must conduct a difference analysis in usability engineering between domestic and international contexts based on users, usage scenarios, and registration requirements. Based on the analysis, appropriate usability registration materials must be submitted, and if necessary, re-verification of the user interface may be required.
- Medium and Low-Risk Devices: Applicants can submit use error evaluation reports and usability engineering research materials from international markets.
Existing User Interfaces
Existing user interfaces, which have not undergone comprehensive usability engineering lifecycle control (or cannot prove it), can have their safety and effectiveness confirmed through comparative evaluation with equivalent medical devices, focusing on post-market usage issues. If confirmation is not possible, re-verification according to custom user interface requirements is needed. Multiple existing user interfaces can be used for a medical device, but their safety and effectiveness must be confirmed individually and collectively from the perspective of the medical device as a whole.
Combination Use
For devices that achieve their intended use only when combined (e.g., active devices with specific accessories or reagents, or medical devices combined with pharmaceuticals), applicants must verify the user interface from the system level of the medical device. Usability engineering research materials must be submitted within each registration unit based on the level of use risk.
Application Instructions
From October 8, 2024, applications for medical device registration must submit appropriate usability registration materials based on specific circumstances. For devices already under review, there is no need to submit usability registration materials.
- High-Risk Devices: Submit usability engineering research reports.
- Medium and Low-Risk Devices: If product guidelines require usability or related aspects (e.g., simulated use), submit the corresponding registration materials. In other cases, submit use error evaluation reports.
For applications to change the registration of a medical device, there's no need to supplement usability engineering research materials for the pre-change product unless there are substantive changes to users, usage scenarios, or the user interface, in which case the relevant usability registration materials must be submitted. For applications to renew the registration of a medical device, there's generally no need to submit usability registration materials.
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